Reported Oct 3, 2018 · Terminated

The Shockwave S4 IVL Catheters are intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified…

Shockwave Medical, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Shockwave Medical, Inc. · 48501 Warm Springs Blvd Ste 108 · Fremont, CA · 94539-7750

The Shockwave S4 IVL Catheters are intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. Shockwave S4, Peripheral Intravascular Lithotripsy Catheter, CE 0086, STERILE R
ManufacturerShockwave Medical, Inc. 48501 Warm Springs Blvd. Ste. 108, Fremont, CA 94539

Lot codes and dates: Catalog No. Part No. Size Lot # UDI (DI Portion Only)
S4IVL2540
FG61163-2540
2.50x40mm
P180222I
M732S4IVL25400
P180327A
P180410A
P180503A
S4IVL3040
FG61163-3040
3.00x40mm
P180223A
M732S4IVL30400
P180327B
P180410B
P180503B
S4IVL3540
FG61163-3540
3.50x40mm
P180223B
M732S4IVL35400
P180327C
P180410C
P180503C
S4IVL4040
FG61163-4040
4.00x40mm
P180223C
M732S4IVL40400
P180327D
P180410D
P180503D
Amount recalled: 612

Catheter unable to maintain inflation pressure during treatment (4ATM) and/or during IVL post dilatation (at 6ATM).

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.